In completing a surgical procedure such as a colostomy or an ileostomy it is common to create a stoma to provide a conduit for allowing elimination of waste material from the patient's body. A well known procedure for creating the stoma is to direct a portion of body duct such as the colon or ileum through an opening in the patient's abdominal wall and to suture the body duct to the skin surrounding the opening. A flexible bag appended to the patient's body collects and retains liquid, solid and gaseous waste material eliminated through the stoma.
U.S. Pat. No. 3,565,073 shows such a procedure for creating a stoma, and also shows one way of appending the flexible bag to the patient's body. A magnet implanted beneath the patient's skin (cutaneous layer) attracts a magnetic ring to which the flexible bag is secured.
Another way of appending a bag to a patient's body is by means of an adhesive and gummy sealant about the stoma to hold and seal the device to the skin of the patient. Such materials have been found to cause irritation of the skin about the stoma and discomfort to the patient. Belts have also been used to hold the bag tightly against the stoma. However, belts have not been satisfactory in obviating the need for adhesives.
With a flexible bag appended to the patient's body passage of waste material into the bag is generally uncontrollable and may also be embarrassingly audible and otherwise detectable. Also, the bag may become uncomfortable as it fills with waste material.
Additionally, stomas created by the above-described procedures are often subject to postoperative problems, some of which can become serious enough to require postoperative treatment or further surgery.
For example, colostomy stomas are sometimes subject to postoperative herniation. A weak spot in the abdominal wall may occur at the point where the colon passes into the abdominal wall. Herniation may occur by the small or large intestine being forced into the abdominal wall at that weak spot. Such herniation can result in a serious blockage, and/or discomfort requiring surgery to correct it.
Another problem which may be experienced with a stoma created by the above-described procedure is postoperative prolapse of the colon or ileum. This can occur when intraabdominal pressure forces the colon or ileum to literally turn inside out and protrude in such a manner as to prolapse internal sections of the colon or ileum through the opening in the body wall. Again, surgery may be necessary to correct such a problem.
Still further, a potential problem with a stoma created by the above-described procedure is postoperative stricture forming in the stoma particularly at about the cutaneous (skin) level. Surgery may also be necessary to correct this problem.
A still further potential problem is serositis or inflamation of the serosa of the colon or ileum due to exposure of the body duct to air. This problem is particularly acute in stomas which are formed by suturing the colon or ileum directly to the skin surrounding the opening in the abdominal wall and especially when serosal surface is exposed to air. Serious inflamation can require treatment, or even surgery.
The foregoing types of problems may become serious enough to dictate corrective surgery, and may even require creation of a new stoma in a different location. Thus, there is always a possibility that a stoma created by such procedures may not be a permanent stoma.
A prior art device which has been suggested for implantation in the patient's body is disclosed in U.S. Pat. No. 3,646,616 (Keshin). The patent discloses a prosthesis for implantation around the urethra and various methods of treating urinary incontinence. The prosthesis includes a flexible mesh of biocompatible material implanted in a portion of body tissue about the urethra and having a resilient portion outside of the body coated with a water resistant coating. The patent discloses that the resilient portion outside of the body can be closed by a removable cap. The patent broadly suggests that the device could be used for colostomies or ileostomies, but does not disclose how the device could be so used. Also, the disclosed device, if used in a colostomy or ileostomy appears, nevertheless, subject to certain of the problems of prior art stomas such as for example, postoperative herniation, stricture of the duct, prolapse, etc.
Other types of devices designed for implantation in a patient's body are discussed in a paper entitled "Carbon Urinary Conduits--Animal Experiments" by Longley et al., Prac. Animal Meet. American Urologists Association 1977, and also in a paper entitled "The Quest for Continence" by Tenney et al., American Society of Colon and Rectal Surgeons, Vol. 21, No. 7, 1978. The papers both disclose a vitreous carbon conduit implant for a bladder vesicostomy; the latter paper further discloses a carbon conduit having a fenestrated flange thereon.